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www.mirrorreview.com
February 2019
Spirituality & Success
Benefits of Spiritual Practices For
Successful Professional Life
Trending
Top 5 reasons the novel eye-drilling
Nanobots could cure complex
eye diseases
Performing Bioanalysis To Optimize Drug
Development With Uncompromising Precision
Mike Suga
President & CEO
CMIC, Inc.
EDITOR’S LETTER
Challenges bringing opportunities in the biotech and pharma industry
Given the very nature of its business, the biotech and pharmaceutical industry is continuously faced with
challenges like cost aspects and stricter regulations. Similarly, these challenges are met with new trends
that help navigate these issues and lead to new growth opportunities. Powered by the emergence of
bioanalytics and advancements in genetics, the usefulness and safety of biopharmaceutical products
have developed the ability to address previously untreatable conditions. This positive shift is therefore
enabling the biotech and pharma companies to tackle high prices of drugs with innovative research and
developments.
Considering the high growth and drastic progress in the biopharmaceutical product development, we
have featured prominent companies in our latest magazine, “The 10 Best Biotech & Pharma
Companies to Keep an Eye On in 2019”. With their state-of-the-art approach, these leading companies
are contributing the biotech and pharma industry.
Out of these phenomenal organizations, we are privileged to feature CMIC Inc. on the cover of this
magazine. CMIC Inc. has years of excellence in bioanalytical services. The President and CEO, Mike
Suga is leading the company with a strong commitment to improving the lives of people around the
world, ultimately enabling the organization to prosper with new achievements.
Rolling to the next pages, we have covered innovative stories of leading biotech and pharma companies
which are working towards enhancing the industry with advanced researches and products.
This time, the team of Mirror Review has invited López Fernebrand (Senior VP, General Counsel &
Corporate Secretary/Amadeus) to explain his expert viewpoints. López shared his opinions regarding
the essence of technology for sustainable travel industry.
As our promise to delight our precious readers with amazing articles, we bring you two articles covering
the subjects related to spirituality in life and a novel nanobot technology.
I hope you enjoy this info-packed magazine issue.
Happy reading!
Mayur Shewale
Assistant Editor
CREDIT PAGE
Mirror Review Media & Tech
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Vikram Suryawanshi
Managing Editor :
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Project Managers : Abhishek Patil
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10
Performing Bioanalysis To
Optimize DrugDevelopment
With Uncompromising
Precision
CMIC Inc:
COVER STORY
ARTICLES
Benefits of Spiritual Practices For
Successful Professional Life
Spirituality & Success
Top 5 reasons the novel eye-drilling
Nanobots could cure complex eye diseases
Trending
20 32
EXPERT’S VIEWS
Why technology is crucial to
achieving a sustainable
travel industry ?
Tomas López Fernebrand | Amadeus
26
CONTENTS
18
Bringing Breakthrough Cell Therapy
Treatments to Frail Patients by Replacing
Toxic Chemotherapy with a Better Alternative
AVM Biotechnology:
24
30
36
Producing High-Quality Biopharmaceutical
Solutions with Superior Research
and Methods
Driving Sustainable Growth in the
Global Generics Market
Proven Leaders in Stem Cell-based
Regenerative Medicine
BIA Separations:
SANDOZ Inc:
Vitro Biopharma:
Mike Suga
President & CEO
COVER
STORY
Performing Bioanalysis To Optimize Drug
Development With Uncompromising Precision
&
Companies to Keep an Eye on in
2019
BEST
In today’s healthcare industry,
medicine is becoming more
and more personalized with
patient focused approach. To drive
such a personalized medicine
avenue, Biomarker is a good
example and a leading contract
research organizations (CRO) like
CMIC, Inc. have a responsibility
to provide bioanalytical data
meaningful enough for advanced
medicines.
CMIC, Inc. is a leading CRO and a
provider specialized in
bioanalytical services in support of
toxicokinetics (TK) as well as
pharmacokinetics (PK) studies for
both pre-clinical and clinical
developments, along with
pharmacodynamics (PD)
biomarkers. Located near Chicago,
CMIC provides cutting-edge
capabilities and sophisticated
expertise in bioanalytical method
development, method
validation/qualification, and study
sample analysis for small and large
molecules as well as
oligonucleotides. As a strategic
drug development partner, CMIC
helps sponsors to overcome
employs more than 6,000
employees worldwide with nearly
$700M in sales revenue reported in
2018. Initially, CMIC grew in Asia
Pacific countries and most recently,
it expanded in the United States.
Furthermore, CMIC Group
acquired a Contract Development
Manufacturing Organization
(CDMO) in Cranbury, New Jersey,
and JCL Bioassay, the bioanalytical
test facility in Hoffman Estates,
Illinois, which is currently known
as CMIC, Inc.
After the acquisition, CMIC, Inc.’s
laboratory in Hoffman Estates
completed construction of an
additional 5,000 sq. ft. of dedicated
laboratory space, bringing its
current footprint to 27,000 sq. ft. on
over 5 acres of buildable land.
Currently, it houses nearly 20 LC-
MS/MS instruments, bringing the
CMIC global count to
approximately 50 LC-MS/MS
instruments. This addition provides
with extensive testing capabilities
and sample storage space to support
increasing study demands.
challenges in bioanalysis with
expertise, rapid turn-around-time,
and high quality services.
History of Reputation and
Continued Success
CMIC has over 30 years of
experience in bioanalytical analysis
with a reputation for excellence and
a strong commitment to helping
improve lives of people around the
world. With dedication to the drug
development market and continued
success, CMIC has become a
leading CRO in Japan and North
America. Today, CMIC continues
to grow and expand its facility and
capabilities to meet the needs of
clients and the changing drug
development environment.
Growing Worldwide with its
Services and Acquisitions
Founded in 1992, CMIC Group
became the first company to
provide Contract Research
Organization (CRO) services that
are essential for conducting clinical
trials in Japan. Today, CMIC
We help clients to streamline drug
development efforts to maximize
success rate by reducing drug
development time and costs.
COVER STORY
Managing High Volume Projects
with World Class Facility
Its Japan oriented-high quality,
quick turn-around-time, and
flexibility differentiates CMIC from
its competitors. Following theses
Japanese quality norms, CMIC’s
GLP-compliant state-of-the-art
facility has grown to accommodate
quick turnaround and high volume
projects from around the country.
Conveniently located in Hoffman
Estates only 20 minutes from
Chicago O’Hare International
Airport, CMIC’s location in the
Midwest helps the leading CRO to
conveniently serve pharmaceutical
and biotechnology companies
across the country.
Purpose-built in 2008 to maximize
efficiencies and provide scientists
with a world-class quality
environment, CMIC is equipped
with features like on site
emergency back-up power supply,
Biosafety Level 2 lab, UV-free lab,
controlled substance license
(schedule III-V), temperature and
profits sustainable for shareholders,
employees, clients, and societies.
Mike earned bachelor’s and
master’s degrees in agricultural
biosciences from University of
Tokyo. Today, he is based in
Chicago, where he serves as the
Senior Vice President of CMIC
HOLDINGS Co., Ltd., reporting
directly into the CMIC Group’s
Tokyo Headquarters.
Highly Skilled Staff at CMIC
CMIC researchers are committed to
the advancement of medicine. With
every project, they provide
unsurpassed excellence and
innovative solutions driven by
CMIC’s core values of trust,
teamwork, dedication, respect, and
integrity. These highly educated
and experienced scientists work
directly with clients’ R&D
scientists to ensure the best output
from investments. CMIC’s project
team is comprised of two technical
experts for each assay performed to
provide continuous verification of
the assay conducted.
humidity monitoring systems,
video security and restricted entry,
on site or off site archives, building
management systems, and state-of-
the-art sample monitoring system
(24/7).
Friendly CEO Leading CMIC
towards New Opportunities
“Personalized medicine is out there
and it is on us by leading in
bioanalytical services that clients
can trust to deliver high quality
data, rapid turnaround, and
unparalleled customer service”,
says Mike Suga, the President and
CEO of CMIC, Inc., when asked
about the utilization of
bioanalytical services to enhance
personalized medicine.
Mike likes to engage with his team
members by motivating them to
maintain a healthy work
environment. At CMIC, Mike
engages with both scientific and
supporting teams throughout the
company’s strategy and operation
as well as delivers revenues and
Our mission is to contribute to high
quality, efficient drug development
and conduct science that
contributes to the public welfare.
&
Companies to Keep an Eye on in
2019
BEST
Technical expertise is shared and
developed through extensive cross
training between CMIC’s international
laboratories. As testing methods and
technology continue to improve at a
rapid rate, researchers at CMIC are
committed to staying at the forefront of
progress with on-going education and
training. Such regular external training
from vendors and industry experts and
regular attendance at industry
conferences keeps researchers of
CMIC up-to-date on the latest
technology and techniques.
Providing Best-In-Class Results with
CMIC’s Quality Commitment
The Quality Assurance Unit (QAU) at
CMIC was established to provide data
quality and study integrity in
accordance with Good Laboratory
Practice (GLP) regulations. With more
than 20 years of combined experience
of inspecting and auditing studies
designed to comply with the US FDA
and EPA as well as international
regulations such as OECD and JMHW
GLPs, CMIC QAU staff members are
long-experienced Quality Assurance
Professionals in Good Laboratory
Practice (RQAP-GLP). To assure high-
quality, each QAU staff member at
CMIC receives on-going training and
education in Quality Assurance.
COVER STORY
Our vision is to become the
most respected and trusted
bioanalytical laboratories in
the world.
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Company InfoCompany Name
3Scan
Todd Huffman
CEO
A one-stop shop for digital and computational pathology, 3Scan’s KESM
produces digital 3D tissue models with micron-scale resolution at 400 times
the throughput of traditional microscopes.
www.3scan.com
AVM Biotechnology
Theresa A. Deisher
CEO
Founded in 2008, AVM Biotechnology is developing AVM0703—a non-toxic
replacement for chemotherapy preconditioning for CAR-T/NK/TCR/TAC and
other cell-based immunotherapies.
www.avmbiotech.com
BIA Separations
Aleš Štrancar
CEO
BIA Separations is the leading developer of monolith technology and the
exclusive producer of CIM® (convective interaction media) chromatographic
columns for the production, purification, and analysis of large biomolecules.
www.biaseparations.com
Endo Pharmaceuticals
Paul V. Campanelli
President & CEO
Endo Pharmaceuticals Inc. engages in the research and development,
production, sale, and marketing of branded and generic pharmaceutical
products primarily in the United States.
www.endo.com
Ipsen is a global specialty-driven biopharmaceutical group committed to
discovering new solutions for targeted debilitating diseases and improving
quality of life for patients.
www.ipsen.com
Novo Nordisk is a global healthcare company with more than 90 years of
innovation and leadership in diabetes care.
www.novonordisk.com
Sandoz is a global leader in generic pharmaceuticals and biosimilars.
www.us.sandoz.com
Established in 1986, Vitro Biopharma provides a unique mix of research and
clinical products used by leading universities and institutions worldwide.
www.vitrobiopharma.com
CMIC
Mike Suga
President & CEO
CMIC, Inc. is a leading CRO and a provider specialized in bioanalytical
services in support of toxicokinetics (TK) as well as pharmacokinetics (PK)
studies for both pre-clinical and clinical developments, along with
pharmacodynamics (PD) biomarkers.
www.cmic-inc.com
Ipsen
David Meek
CEO
Novo Nordisk
Lars Fruergaard Jørgensen
CEO
SANDOZ Canada Inc.
Carol Lynch
President, Sandoz US,
& Head of North America
Vitro Biopharma
Dr. Jim Musick
President & CEO
&
Companies to Keep an Eye On in
2019
BEST
Crescent Pharma Limited is committed to ensuring the manufacture of
medicinal products to the highest quality, safety and efficacy by adhering to,
and implementing quality systems in compliance with GMP and GDP.
www.crescentpharma.com
Crescent Pharmaceuticals
Ajeet Nigam
CEO
Bringing Breakthrough Cell Therapy Treatments To Frail Patients
By Replacing Toxic Chemotherapy With A Better Alternative
According to the
American Cancer
Society, children
treated with chemotherapy
have a 3 to 13 times increased
risk of getting another cancer
within a span of 20 to 30 years
of treatment. Despite this,
chemotherapy remains the
widely accepted and standard
regimen for children with
cancer. Developed as
alternatives to chemotherapy
over the past decade,
treatments like Protein Kinase
Inhibitors, Proteasome Inhibitors,
and new Biologic Antibodies have
unfortunately been a
disappointment in the community
setting and 41% of blood cancer
patients choose to stop taking these
treatments due to the physical and
financial toxicities. In most cases,
blood cancer patients relapse and
expire rapidly after stopping
treatment.
Unfortunately, chemotherapy
remains an integral aspect of cancer
treatment, and is a required pre-
conditioning before transplant or
the newly approved CarT therapies.
Chemotherapy comes at a price of
toxic, sometimes life-threatening,
side effects such as: Nausea and
Vomiting, Mucositis, Leukopenia,
Thrombocytopenia,
Granulocytopenia, Neutropenia,
Cardiotoxicity, Infections,
Pneumonia, Anemia, and Hair
Loss. Therefore, in the Hematology
as well as Oncology field, new non-
toxic solutions are needed to reduce
the physical and financial toxicities
of conventional treatments.
Founded in 2008, AVM
Biotechnology is developing
AVM0703—a non-toxic
replacement for chemotherapy
preconditioning for CAR-
T/NK/TCR/TAC and other cell-
based immunotherapies.
Specifically, AVM’s R&D is
dedicated to the discovery,
development, and
commercialization of stem cell-
enabling technologies for
regenerative medicine, immuno-
oncology, and fully human
biologics applications.
AVM’s Fight against Human
Exploitation
Based in Seattle,
Washington—AVM Biotechnology
is on the mission to end human
exploitation whether it is physical
or financial. Physical exploitation
includes selling of organs in the
black market and financial
exploitation would include the non-
reimbursement of fees in the newer
cancer and autoimmunity
treatments. Exploitation also
includes the absence of non-
injurious treatments for particular
Theresa A. Deisher
18
CEO
19
contain potentially toxic excipients,
AVM0703 is a new formulation of an
existing API with a composition of
matter patent filed and it is ready for
Phase 2 clinical trials. In addition to
its general anti-inflammatory and
lympho depleting properties,
AVM0703 is dosed to transiently
reduce the size and number of stem
cell binding niches in the secondary
lymphatic system.
CEO’s Multifaceted Work towards
the Mission of AVM Biotechnology
Theresa A. Deisher, the CEO of
AVM Biotechnology is leading the
company on its mission to reduce
physical and financial toxicities of
cancer and autoimmune treatments,
which will ultimately improve
patients’ quality of life. At AVM
Biotechnology, Theresa oversees all
the Research and Development as
well as clinical development. She
also handles patent strategy and
patent writing. Moreover, the multi-
talented CEO looks at recruitments
of key personnel to further expand
the corporate capabilities of AVM
Biotechnology. Along with these key
patients like the elderly, children, the
poor or disabled.
AVM has set its goal to fight against
such exploitation and work towards
improving patients’ quality of life,
reducing physical and financial
toxicities of cancer and autoimmune
treatments, and the elimination of the
dread a cancer or autoimmunity
diagnosis brings to patients and their
loved ones. AVM0703 acute actions
are relatively selective for
lymphocytes, reducing the risks of
infection, the need for
hospitalization, transfusion
requirements and patient toxicities.
After a single acute IV dose, it
delivers rapid clinical responses
within 24 hours. Importantly,
AVM0703 treatment can be safely
repeated upon relapse allowing
cancer or autoimmunity to be either
cured or made chronic with good
quality of life.
How AVM0703 Reduces Toxicity?
AVM0703 is used alone, or in
combination with stem cell-based
therapies, to significantly enhance
stem cell tumor targeting and
engraftment. AVM0703
lymphoablates all compartments and
has the ability to replace
chemotherapy preconditioning before
transplant or adoptive cell therapy. It
can be used as a stand-alone
treatment which is projected to
induce remission in
relapsed/refractory lymphocytic
blood cancers and patients with
autoimmune disease who have not
responded to DMAIDs (Disease-
modifying anti-inflammatory drugs).
As compared to commercially
available versions of the API, which
We strive to develop
products like
AVM0703 that will
end human
exploitation in
biomedical research
and medical
treatments.
&
Companies to Keep an Eye On in
2019
BEST
aspects, Theresa takes care of fund
raising for new developments and
improvements in the existing
programs at AVM Biotechnology.
Strategies to Reach Under-
Developed Nations with New
Partnerships
When asked about her long term
plans for AVM Biotechnology,
Theresa said that they have plans to
partner with a global pharmaceutical
company for worldwide clinical
development and commercialization
of AVM0703 and their second
generation candidate. An important
part of their long-term mission is to
provide AVM therapies to under-
developed regions of the world.
Additionally, Theresa and her team
are working on accelerating clinical
trials in autoimmunity and use of
AVM0703 as a non-toxic
preconditioning agent to optimize
stem cell regenerative effects. For
this, they are leveraging clinical
dosing and safety data from
relapsed/refractory lymphocytic
blood cancer patients, where FDA
commercial approval is rapid. The
revenue generated from AVM0703
will be used to drive another
development program leveraging
induced pluripotent stem cells (iPS).
This program will be useful for
general and patient-specific biologic
manufacturing. Likewise, AVM
Biotechnology will partner and
collaborate with companies who are
developing novel bioreactors and
NGOs to solve supply chain
limitations of vaccine provision in
under-developed countries.
Spirituality & Success
20
S
pirituality in the business is a movement that began
in the early 1920’s and has emerged as a grassroot
movement with individuals practicing spirituality in
the workplace. Most recently, employees have started
looking beyond the jaw-dropping salary packages, and for
them money is not the only prominent motivator of good
job performance, because they want mental satisfaction
from their work as well. The feeling of fulfillment, in other
words, is called as spiritual fulfillment, which is a major
motivator for delivering a better job performance.
Spirituality involves the attempt to seek one’s ultimate
purpose in life, and spirituality in business involves
developing a strong connection with oneself and one’s co-
workers, having ideal beliefs and spiritual values. The
spiritual values include values of work ethics, a good cause
to work for the company, empowerment, and expression of
emotion, which plays an important role in the employee’s
life. Sometimes, spirituality is confused with religious
tradition, but it does not involve a connection to any
specific religion, rather it is based on the individual’s own
personal values and philosophy.
The present article elaborates how the business and
spirituality work together for a successful professional and
personal life.
Ø Daily morning spiritual practices:
The spiritual practices balance the life. The practices
such as meditation, yoga, and breathing exercises help
people to connect with themselves. According to a book
on spirituality written by Florence Scovel Shinn, the
subconscious mind needs programming, and if it’s not
done then someone else will program it. Nowadays,
without spiritual practices, people let others do the
programming through the social media, news, and other
informative mediums filled with a mixed type of
expressions, which disturbs the focused thought process
of an individual. The morning practices make the mind
more focused and program it in such a way that the
employee can sustain the new work challenges and
unexpected events throughout the day. The start of the
day with these spiritual practices awakens the individual
and makes him realize the happiness and peace within
by detaching him from the deep dreams of other
attractions. To make the mind feel great and alert
throughout the day, starting the spiritual practices early
in the morning after a complete 8 hours of sleep is
beneficial as it is very peaceful and quiet in the morning.
After starting to wake up early in the morning, it
becomes a supplement for the healthy expansion of the
entire life. Committing few spiritual rituals every day
can absolutely change the life in a positive way.
Sometimes, it’s difficult to meditate just after waking
up, because many people go back to sleep while
meditating. Taking a simple tea can change the entire
ritual, because the caffeine in the tea is a perfect wakeup
call so that one can work without dozing off. Those who
don’t like tea can sit and write something to regenerate
the energy. Writing opens the thoughts and ideas in the
mind. If an employee is going through a tough time,
writing is the best solution to find out the best solutions.
&
Companies to Keep an Eye On in
2019
BEST
21
Ø Time to connect spiritual source during work:
Most of the successful professional individuals schedule
a break during the day to do walking, meditation and jog
while concentrating on breathing, or they sit quietly
away from everyone and everything to meditate. Sitting
quietly with eyes closed, along with the focus on
breathing will help to clean the mind which is
continuously thinking and analysing about something or
the other. Even if these thoughts come and go, and one
must not be taunted by them. With consistent practice,
they will vanish keeping the mind a quiet place. These
procedures generate the conscious power within and
bring the inner bliss to come out and cherish. An alarm
and a timer will be beneficial for doing such practices.
This small time taken for connecting with oneself
simplifies and makes the workday more successful.
Organizations should promote these practices and create
a calm and healthy atmosphere for them because
employees desire to work in an organization that seeks
to have a high sense of ethics or integrity and makes a
good contribution to the welfare of employees,
customers, and society than the typical company.
Ø Trashing out the negative thoughts:
If the employee is filled up with negative thoughts and
emotions, which are not serving him, then there won’t
be enough space available for receiving the desired
outcomes. Imagine a glass of dirty water filled to the
brim. If one needs to add pure water in it, then it’s not
possible to add pure water in an already full glass. The
same is true for the mind. When the mind of an
employee is full of worries, anger, grudges, judgments
towards co-workers or himself, he won’t be able to
utilize and think about pure thoughts of contentment,
because the mind is already engaged in thoughts related
to other negative feelings. It is essential to trash out such
negative feelings to welcome positive things to happen.
Finding a practice which releases negative emotions is
the best way to deal with the negative thoughts because
only a calm and happy mind can understand the inner
intuition or the gut. A clear and happy mind helps
employees understand how they feel about new tasks,
projects, and organizational activities. There is a close
relation between good thoughts and job satisfaction,
because, in work, the positive organizational purpose is
significantly associated with job satisfaction. With an
increase in workplace spirituality, employees’
commitment increases towards the organization.
Ø Spirituality for leadership:
For many years, spirituality and leadership were worlds
apart. While spirituality concerns with intangible ideas
and emotions, leadership is a practical area of scientific
inquiry. However, a large number of evidences from
studies show that these fields are much closer, and there
is a transition between the two figures. A good leader
needs to evaluate the situation and act accordingly. The
key elements of modern leadership involve co-
operation, consideration, agreement, and social quality.
The new adaptability culture requires a leader to be
autonomous, take initiatives for improvements and
emerge with new objectives and strategies. There is
growing interest in the issues related to the spirituality
in the workplace. The spiritual values such as integrity,
honesty, and humility have a great effect on leadership
success. The practices which have been emphasized in
many spiritual teachings, and found crucial for
leadership development are: showing respect for others,
demonstrating good treatment, expressing caring and
concern, actively listening, recognizing and appreciating
the contributions of others, and engaging in reflective
practice. Leadership and spirituality play an essential
role together in terms of ethics and values. Value-based
leaders have the ability to utilize employee efforts and
organizational goals more effectively by connecting
them to the deeper values inside them. They motivate
employees and improve their performance and
commitment towards the organization by making them
imagine a better tomorrow.
The spiritual rituals have an uncanny ability to set the
human mind for the rest of the life. These spiritual practices
also give a loud and clear message that the professionals in
organizations should be versed with their core values
through a positive vision and personal actions. People
commonly believe that there is a conflict between the
values and practices included in spirituality and those
required for successful business, but the above article
explains the huge similarity between elements of success in
both fields. Therefore, by incorporating these spiritual
practices in professional life, employees can align good
values with the strategy and roadmap to achieve massive
success in the business.
Spirituality & Success
22
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flow-independent performance,
low back pressure, and versatility,
resulting in faster separation,
concentration, purification,
removal, and analysis of biologic
materials.
Using unique monolithic columns
and Purification Process
Development, the resulted process
allows for higher yield and purity
of client’s target product. This is
possible due to BIA Separations’
capability to manage the interface
between upstream and
Ales Strancar
CEO
24
Traditional Pharma techniques
have struggled for decades to
make inroads into diseases whose
roots lie deep in molecular biology.
Today’s modern Biopharma has extended
that reach into the foundations of cancer,
heart disease, genetic disease, and a host
of other afflictions. In the coming years,
the therapies and cures offered by this
extended reach will increasingly enable
patients to live longer with productive and
more fulfilling lives. Beyond that, these
modern therapies will also enable the
prevention of numerous diseases and
conditions that have plagued humanity for
centuries.
Established in 1998, isBIA Separations
the leading developer of monolith
technology and the exclusive producer of
CIM®, Convective Interaction Media
chromatographic columns for the
production, purification, and analysis of
large biomolecules.
Core Focus Areas of BIA Separations
BIA Separations specializes in the
organization, supporting and
motivating employees, formulating
policies, overseeing organizational
operations, looking for future
opportunities, implementation of plans,
and much more. In addition to these
roles and responsibilities, the energetic
CEO of BIA Separations also likes to
be a part of the new product and
process development.
Standing Apart from Competitors
with High-Performance Products
BIA Separations is always one step
ahead of its competitors with its
genuinely unique and extraordinary
fractionation performance. No other
chromatography media format can
match monoliths for capacity, speed,
resolution, recovery, and convenience,
especially with very large products like
DNA plasmids, RNA, virus particles
for vaccines and viral vectors, and
extracellular vesicles. In addition,
Slovenia-based company’s deep hands-
on experience with method
development for these same products
puts its customers years ahead with
process development, clinical
evaluation, and manufacturing. Other
than its products, BIA Separations is
known for its following best-in-
classfacilities comprising:
1. Process Development:
As a contract research organization,
downstream processes, which is the
key for complex biologics production,
and use of monolithic chromatographic
resins, which provide the best
performance for complex biomolecule
purification.
Ÿ Products for Analytical
Applications: CIMac™ Analytical
Columns combine all elaborate
®
characteristics of CIM monoliths at
analytical scale and are perfect tools
for analysis and control of
manufacturing processes as well as
they are ideal for process analytical
technology (PAT).
Ÿ Products for Preparative
Applications: CIMmultus™ is the
new and improved line of pre-
packed chromatographic monolithic
columns distinguished by large
flow-through channels, designed for
working with large proteins like
IgG, IgM, PEGylated, and VLPs
along with viruses like AAV,
adenovirus, lentivirus, influenza,
bacteriophages, and pDNA.
TM
Ÿ PATfix : Using CIMac™
TM
analytical columns, the PATfix
HPLC system gives “at-line”
analysis for the control of impurities
and critical quality components
using HPLC fingerprinting.
CEO’s Contribution to BIA’s
Success
Since taking over the responsibility as
the CEO of BIA Separations, Ales
Strancar has been enhancing the
capabilities of the leading
biopharmaceutical solutions provider
company. With a goal to make BIA
Separations as the number one supplier
of purification products and supporting
services in the field of Gene Therapy,
Ales handles numerous roles and
responsibilities, which consists of
managing the company, making
everyday business decisions, advising
the Managing Board, promoting
We offer a whole
toolset for
chromatographic
analyses of
molecules in up
and downstream
processes in
minutes.
BIA Separations’ facilities are fully
equipped to handle process and
analytical method development for
particles up to biosafety level 2.
Considering clients’ demands in
mind, its sales and technical
support team prepares a work plan
as per their requirements.
Moreover, clients’ may choose to
be involved throughout the
development via regular contact
with the project manager.
2. Downstream Process
Development:
Ÿ Processes suited to different clinical
phases up to market supply are
developed exclusively on
monolithic columns starting from
lysis or capture to final polishing
and formulation of biomolecule like
viruses, pDNA, bacteriophages,
extracellular vesicles, proteins,
PEGylated proteins, etc.
Ÿ Depending on clients’ products and
requirements, the multistep process
includes development of lysis
method, chromatographic media
selection and optimization, virus
inactivation, filtration, and
tangential flow filtration.
Ÿ Recommendation of suitable
analytical methods.
Ÿ Tech transfer of standard operating
procedures (SOP) to client’s facility
or CMO.
3. HPLC Analytical Methods:
Ÿ Methods for in-process control
(PAT), which are developed to
increase control, improve
efficiency, and prevent rejection of
batches of upstream and
downstream.
Ÿ Methods for final control that
enable real-time release of
products.
Ÿ BIA’s HPLC methods use CIMac™
Analytical Monoliths and are
developed on PATfix™ along with
reference methods for
characterization. All these methods
can be validated.
25
&
Companies to Keep an Eye On in
2019
BEST
Do you believe in the importance of a
sustainable travel industry? The travel and
tourism sector is expected to grow at an
annual rate of 3.9% over the next decade. That is
positive, but it also reminds us that we need to put in
place measures to guarantee the sustainability of the
sector in the long term. Amadeus takes this very
seriously. Let me tell you why.
We consider that a company’s responsibility goes
beyond securing the growth of its results. At Amadeus
we have a record for many years of limiting the
environmental impact and optimizing the social reach
of our commercial operations. We believe that
environmental efficiency has to start with our internal
operations. That is why we measure our
environmental impact in order to identify
improvements and implement solutions. Since 2009,
we have been using the Amadeus Environmental
Management System (EMS) as a solid methodology to
analyze all our environmental data and help us
identify and take measures to improve environmental
performance.
As a technology provider for the travel and tourism
sector, Amadeus develops technology solutions that
help our customers improve their environmental and
economic efficiency. One of our technology solutions,
Amadeus Altéa Departure Control-Flight
Management, allows airlines to accurately calculate
the fuel they need for a given flight, allowing them
significant savings in CO2 emissions, fuel and
economic costs.
To achieve greater long-term results, we collaborate
with other interest groups in the travel industry and
participate in projects to improve environmental
sustainability. For example, in order to help achieve
the 2-degree objective set by the Paris Agreement and
reach the carbon neutral level, Amadeus joined the
United Nations’ Climate Neutral Now commitment.
We have also established a long-term agreement with
the International Civil Aviation Organization (ICAO)
to contribute to a greater awareness of carbon
emissions in aviation. Amadeus uses the ICAO carbon
emissions calculator on its distribution platforms to
provide travelers with information on the greenhouse
gas emissions produced during their trips.
Why
TECHNOLOGYis
Crucial to Achieving a Sustainable
TRAVEL INDUSTRY?
Expert’s Views
26
Amadeus’ environmental commitment is reflected in
our inclusion in several global sustainability indices.
Among others, Amadeus has been chosen as one of
the most sustainable companies in the world, ranking
16 in the 100 global companies chosen by Corporate
Knights in 2018. In addition, our efforts in this regard
have been recognized by the Dow Jones Sustainability
Index for seven consecutive years.
Looking at the social level, we believe that travel can
play a key role in global economic development and
can be a determining force for positive change.
We seek to actively contribute to the communities in
which we work, through investment, participation in
local projects and partnerships with non-profit
organizations around the world. To do so, during 2017
we developed 138 community support and social
assistance projects and 69 training projects, providing
young people with the qualifications required by the
digitized sector of travel and tourism.
In 2013, Amadeus launched Click for Change, a
program that, thanks to the donation engine developed
by Amadeus, allows donations from people who buy
their trips online. So far, travelers have donated almost
3 million dollars on the websites of Iberia, Finnair,
Norwegian, Almundo and Avianca for programs to
educate and vaccinate of children, and other
development projects run by the United Nations Fund
for Children (UNICEF).
We also contribute our knowledge in travel
intelligence for initiatives that benefit society. In this
sense, Amadeus is part of a UNICEF global
innovation program that collects and analyzes
complex data sources from different sectors. In part,
thanks to the data provided by Amadeus, they can
better understand the patterns of the spread of
epidemics, which helps them to control possible
outbreaks in other areas.
Our purpose to shape the future of travel and tourism
is based on internal, external and collaborative actions
with other entities in the sector. We are committed and
proud to be able to use Amadeus’ technology,
experience and global network to ensure the
sustainability of the travel industry in the long-term
and build a better future for all.
Senior Vice President, General
Counsel & Corporate Secretary,
Amadeus
Tomas López Fernebrand
27
&
Companies to Keep an Eye On in
2019
BEST
Driving Sustainable Growth In The
Global Generics Market
Sandoz is a global
leader in generic
pharmaceuticals and
biosimilars. As a division of
Novartis, its purpose is to
discover new ways to
improve and extend people’s
lives by pioneering novel
approaches to provide access
to high-quality medicines.
Global headquarters are in
Holzkirchen, Germany and
US headquarters in
Princeton, New Jersey.
With its experience and
capabilities in the
development, manufacturing and
commercialization of medicines,
Sandoz is committed to
increasing patient access to high-
quality, life-enhancing biosimilars
and Value-Added Medicines
(VAMs). According to estimates,
1.2 million US patients could
gain access to biologics alone by
2025, which is beneficial to all,
particularly the elderly, women
and those with low or fixed
incomes. Sandoz is boldly
trailblazing novel approaches to
supporting the growing healthcare
needs across the world.
Reducing the Rising Treatment
Cost with Biosimilars and
Generic Medicines
As it continues to reimagine
medicine, Sandoz has focused its
strategy on specialization in
biosimilars, VAMs, complex
generics and prescription digital
therapeutics, in order to
contribute to helping patients gain
access to cost-effective and
advanced health treatments.
Of note are three medicines that
held top market share positions in
®
2018. Zarxio (filgrastim-sndz),
which stimulates growth of
certain white blood cells
important to fighting infection,
®
Omnitrope (somatropin
injection), a human growth
®
hormone, and Glatopa
(glatiramer acetate injection) for
relapsing forms of multiple
sclerosis. As of October 2018,
®
Zarxio led with over 45% share;
®
Omnitrope reached its highest
total prescriptions (TRx) share
with over 24% in a seven-player
market and growth of more than
®
20% and Glatopa 20 mg/mL
continued as the market leader
with 38% TRx share.
The successful adoption of
®
Zarxio into clinical practice
saved the US healthcare system
about $500 million in less than
two years.
Backing the Prescription
Digital Therapeutic (PDT)
Arena
Another exciting milestone on its
Carol Lynch
President, Sandoz US &
Head of North America,
Sandoz Inc.
30
31
of an originator reference product
in the US and remains in the top
spot in volume share.
Carol Lynch, Leading the US
Transformation of Sandoz
Carol Lynch has worked with
Sandoz and Novartis for more than
20 years in various roles across
several continents. Due to her
dedication and extensive
experience with Sandoz and
Novartis, Carol became President,
Sandoz US, Head of North
America, Sandoz Inc. in March
2018 and is a member of the global
Sandoz Executive Committee.
Carol oversees commercial
operations in the US (the largest
commercial and country
organization) and Canada and looks
after 35% of Sandoz’s global
revenue.
journey to reimagine Sandoz was
expanding its presence in the
digital world. It has collaborated
with Pear Therapeutics, enabling it
to leverage new technologies and
be at the forefront in the digital
revolution. In December 2018,
®
Sandoz launched reSET , the first
and only FDA-authorized
Prescription Digital Therapeutic
(PDT) that leverages technology to
strengthen Substance Use Disorder
(SUD) therapy. Further, in January
™
2019, it launched reSET-O , the
first FDA-cleared PDT for patients
with Opioid Use Disorder (OUD).
These flagship launches are proof
of Sandoz’s dedicated efforts in
identifying innovative solutions to
major healthcare issues like the
opioid abuse crisis in the US.
Biosimilars as the Solution for
Expensive Health Treatments
As stated by the Association for
Accessible Medicines (AAM),
biosimilars have the potential to
improve the quality of life for
American patients and save billions
of dollars each year. It is estimated
that biosimilars could save the US
healthcare system more than $54
billion over 10 years.
Sandoz was the first company to
bring biosimilars to US patients. It
is also further backing the
movement for cost-effective
medicines with eight biosimilar
medicines approved worldwide.
®
Sandoz’s Zarxio is the first
biosimilar to overtake market share
We contribute to
society’s ability to
support growing
healthcare needs
by pioneering
novel approaches
to help people
around the world
access high-
quality medicine.
&
Companies to Keep an Eye On in
2019
BEST
Carol appreciates working with
smart, strategic people because it
helps to promote creativity that will
fuel the reimagining of the US
business. She believes that one
must find purpose in their work and
be empowered to improve ways of
working to more positively impact
patient’s lives.
Currently, Carol and her team are
taking bold actions to transform the
US business for sustainable long-
term growth. To create higher
future value, Sandoz is reshaping
its portfolio to complement
complex generics and biosimilars
with VAMs and prescription digital
therapeutics.
According to Carol, the company
will continue to explore and
implement cost-effective
biosimilars, complex generics, and
PDTs to innovate more accessible
solutions that will enrich people’s
lives.
When asked about her upcoming
strategies for Sandoz, Carol asserts,
“Our work is not close to being
finished. We have several exciting
new product launches planned for
early 2019, with more to come
throughout the year. We are
working hard to bring our own
portfolio to the market, but more
importantly, we are seeking
innovative partners who need a
strong commercialization
collaborator to bring their products
to market, too.”
Ateam of scientists created specially coated
nanometer-sized vehicles that can be used to move
through dense tissue of the eye. Until now,
scientists have successfully transported nanobots or nano-
vehicles in model systems or through biological fluids. This
is the first time nanobots could drill into a real tissue of
eyeball. These nanobots are just 500 nm wide and they can
easily roam through the tight molecular matrix of an eye.
To go further, a clear idea about nanobots is essential.
What are nanobots or nanorobots or nano-vehicles?
Nanobots are the robots of size close to the microscopic
−9
scale of a nanometer (10 meters). So far, nanorobotics
considered as hypothetical nanotechnology engineering
discipline of designing and building nanorobots.
When nanobots in medicine are considered, the most
popular idea is self-propelled nanomotors and other
biodegradable nanodevices made of bio-nano components.
They are used to carry cargo to the target sites. It means
they deliver drugs to diseased cells.
Such drug delivery approach promises an effective and
improved transport of drugs compared to conventional
methods. For instance, scientists can program nanorobots to
transport essential drugs to remove blood blockages, which
can cure the tumors.
A team of international scientists of the Micro, Nano and
Molecular Systems Lab at the Max Planck Institute for
Intelligent Systems in Stuttgart performed comprehensive
research on these eyeball-drilling nanobots.
The research is named as “A swarm of slippery micro-
propellers penetrates the vitreous body of the eye”, by
Zhiguang Wu, Jonas Troll, Hyeon-Ho Jeong, Qiang Wei,
Marius Stang, Focke Ziemssen, Zegao Wang, Mingdong
Dong, Sven Schnichels, Tian Qiu, Peer Fischer, published
in Science Advances (2018).
Based on the above research, this article covers some
aspects of these novel nanobots and their role in curing eye
diseases.
Here are some of their key features:
32
Trending
Top5the novel eye-drilling Nanobots
could cure complex eye diseases
reasons
Ÿ A size which can easily roam inside an eye
Covered in a non-stick coating, these nano-drills are
500nm wide size approximately matches the mesh size
of the network in the vitreous. They are helical in shape
and 200 times smaller than the diameter of a human
hair. This size is even smaller than a bacterium's width.
Researchers call it slippery micro-propellers.
Ÿ Slippery surface coating inspired by nature
Most tissues including the vitreous have a tight
macromolecular matrix that acts as a barrier and
prevents its penetration. Surprisingly, the slippery
coating on these nanobots removed this barrier of
penetrations. This enables the nanobots to move in the
vitreous seamlessly.
The slippery exterior allows them to be actively
propelled through the vitreous humor to reach the retina.
Primarily, all this happens without damaging the
sensitive biological tissues around them.
One of the authors of the study, Zhiguang Wu explains,
“For the coating, we look to nature for inspiration”.
Further, he added, “In the second step, we applied a
liquid layer found on the carnivorous pitcher plant,
which has a slippery surface on the peristome to catch
insects. It is like the Teflon coating of a frying pan.”
The first film of slippery coating on these nanorobots
consists of molecules bound to the surface, while the
second is a coating with liquid fluorocarbon. This clever
combination enables the nanorobots to go through the
tight mesh of the eyeballs dense tissue.
This slippery coating is crucial for the efficient
propulsion of robots inside the eye, as it minimizes the
adhesion between the biological protein network in the
vitreous and the surface of nanorobots.
Ÿ Targeted delivery
Traditional delivery methods rely on the random,
passive diffusion of molecules. These methods do not
allow for the rapid delivery of a concentrated cargo to a
defined region of the eye. The use of particles promises
targeted delivery but faces the challenge of
macromolecular resistance.
33
&
Companies to Keep an Eye On in
2019
BEST
34
Trending
Proven Leaders In Stem Cell-based
Regenerative Medicine
The Need for
Regenerative
Therapies
It is clear that the current
healthcare sector needs a
shift towards regenerative
therapies to help the
correction of underlying
diseases by utilizing innate
healing systems as opposed
to therapies based on
symptomatic interventions
with attendant side effects,
comorbidities and excessive
costs. By “Harnessing the Power
TM
of Cells , the US-based Vitro
Biopharma is focused on
achieving the full potential of
regenerative medicine.
Established in 1986, Vitro
Biopharma provides a unique mix
of research and clinical products
used by leading universities and
institutions worldwide. Over the
last 25 years, it has been
providing human stem cell lines
and related primary cells for use
in research, drug
discovery/development, and pre-
clinical studies.
Vitro provides a unique
competitive advantage through
the supply of the highest quality
stem cells coupled with stem cell
activation therapy and molecular
diagnostics to track relevant
biomarker profiles, allowing the
assessment of stem cell
regeneration. Along with this
extensive experience, Vitro
possesses expertise in highly-
regulated, commercial biologics
manufacturing. The Company is
ISO 9001:2015 certified, cGMP
compliant, FDA and CLIA
registered as well as ISO
13485:2016 compliant.
International Stem Cell Trials
utilizing advanced medical
diagnostics and therapies
With its vast history of working
in the healthcare sector, Vitro has
developed innovative products in
medical diagnostics, cancer
research, cell line regeneration,
and stem cells. Essentially, its cell
lines include primary and cancer-
associated fibroblasts and animal
& human mesenchymal stem cells
(MSCs) derived from various
tissues together with MSC-
derived progenitor & terminally
differentiated cells like
dopaminergic neurons,
cardiomyocytes, etc. Similarly, it
carefully tests cell lines for purity,
integrity, and contaminates. This
leading biopharma company is
Dr. Jim Musick
36
President & CEO
37
outcomes are the results of the
dedicated efforts made by Vitro’s
talented CEO and his skilled team.
Through its outstanding portfolio of
products and services and
exemplary contributions to the
healthcare industry, Vitro
Biopharma has received several
elite recognitions. In 2014, it was
recognized by Frost and Sullivan as
a “Thought Leader in Stem Cell
Tools & Technology” in North
America through the Receipt of a
Technology Innovation Leadership
Award. Similarly, the company was
also recognized for its
accomplishments in stem cell lines
and media for supporting global
stem cell research and its
innovative stem cell activation
technology. The company has
numerous national and
international patents and patents
pending on its intellectual property.
also currently focused on stem cell
therapies for a variety of conditions
including neurodegenerative
diseases, musculoskeletal
conditions like osteoarthritis, and
conditions characterized by
inflammation.
The company’s breadth of services
and products is unique in the
industry. Vitro’s strength in
research provides a platform for
extension to clinical studies,
through the supply and knowledge
of all essential components of
modern stem cell therapeutics
under appropriate oversight by
regulatory agencies. The company
has ongoing clinical trials in the
Cayman Islands, New Zealand, the
Czech Republic and has recently
received approval for a new stem
cell therapy trial for
musculoskeletal conditions from
the Ministry of Health in the
Bahamas.
Improved Results with Vitro
Biopharma’s Stem Cell
Activation Product
At present, Vitro Biopharma offers
a nutraceutical product,
NutraVivo™/Brain Grow
Technologies™ for health benefits
of stem cell activation. With the use
of NutraVivo™, the company has
tested successful activation of
human neural & mesenchymal stem
cells by enhanced migration &
proliferation as well as enhanced
gene expression. These superior
Vitro Biopharma
provides and
continually improves
the highest quality
stem cells and related
products and services
in accordance to
government
regulations.
&
Companies to Keep an Eye On in
2019
BEST
CEO, Accelerating Vitro with
Advanced Regenerative Medicine
Applications
Dr. Jim Musick, the President and
CEO of Vitro Biopharma, is
currently handling the operations of
this rapidly growing stem cell firm.
Along with his committed team,
Jim is involved in research &
development and oversees the
essential processes including
intellectual property development,
marketing, sales, business
development and new product
releases.
With his mission to ease patient
care, Jim proudly asserts, “My
greatest pleasure comes from
seeing a patient’s favorable
response to our stem cell therapy.
We are beginning to see advances
in diseases with limited or not
treatment options other than stem
cell therapy” Additionally, with
these continual positive outcomes
and deep insights, Jim is currently
working towards expanding Vitro’s
presence in international medical
tourism while simultaneously
pursuing opportunities in the US
markets such as a new cosmetic
stem cell serum product.
Biotech & pharma magazine
Biotech & pharma magazine
Biotech & pharma magazine

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Biotech & pharma magazine

  • 1. www.mirrorreview.com February 2019 Spirituality & Success Benefits of Spiritual Practices For Successful Professional Life Trending Top 5 reasons the novel eye-drilling Nanobots could cure complex eye diseases Performing Bioanalysis To Optimize Drug Development With Uncompromising Precision Mike Suga President & CEO CMIC, Inc.
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  • 4. EDITOR’S LETTER Challenges bringing opportunities in the biotech and pharma industry Given the very nature of its business, the biotech and pharmaceutical industry is continuously faced with challenges like cost aspects and stricter regulations. Similarly, these challenges are met with new trends that help navigate these issues and lead to new growth opportunities. Powered by the emergence of bioanalytics and advancements in genetics, the usefulness and safety of biopharmaceutical products have developed the ability to address previously untreatable conditions. This positive shift is therefore enabling the biotech and pharma companies to tackle high prices of drugs with innovative research and developments. Considering the high growth and drastic progress in the biopharmaceutical product development, we have featured prominent companies in our latest magazine, “The 10 Best Biotech & Pharma Companies to Keep an Eye On in 2019”. With their state-of-the-art approach, these leading companies are contributing the biotech and pharma industry. Out of these phenomenal organizations, we are privileged to feature CMIC Inc. on the cover of this magazine. CMIC Inc. has years of excellence in bioanalytical services. The President and CEO, Mike Suga is leading the company with a strong commitment to improving the lives of people around the world, ultimately enabling the organization to prosper with new achievements. Rolling to the next pages, we have covered innovative stories of leading biotech and pharma companies which are working towards enhancing the industry with advanced researches and products. This time, the team of Mirror Review has invited López Fernebrand (Senior VP, General Counsel & Corporate Secretary/Amadeus) to explain his expert viewpoints. López shared his opinions regarding the essence of technology for sustainable travel industry. As our promise to delight our precious readers with amazing articles, we bring you two articles covering the subjects related to spirituality in life and a novel nanobot technology. I hope you enjoy this info-packed magazine issue. Happy reading! Mayur Shewale Assistant Editor
  • 5. CREDIT PAGE Mirror Review Media & Tech C-506, Wisteriaa Fortune, Opp-Silver Spoon Hotel, Laxmi Chowk Rd, Bhagwan Nagar, Wakad, Pimpri- Chinchwad, Maharashtra- 411057 +1 (850) 564-8517 info@mirrorreview.com www.mirrorreview.com Publisher : Editor-in-Chief : Archana Ghule Vikram Suryawanshi Managing Editor : Assistant Editor : Contributory Writers : Anuja Mulmule Mayur Shewale Bansidhar Tigga Gopal Khandelwal Deepali Sarwade Akshay Wande Art Director : Visualizer : Graphic Designers : Vinod Alhat Mark Davis Poonam Magdum Sumit Bonage Head of Distribution & Production : Aakash Mahajan Head of Operations : Robert Smith Research Analysts : James Adams Maria Smith David Thomas Advertising : Jacob Eddy Business Development Rohan Yadav Project Managers : Abhishek Patil David Thomas
  • 6. 10 Performing Bioanalysis To Optimize DrugDevelopment With Uncompromising Precision CMIC Inc: COVER STORY ARTICLES Benefits of Spiritual Practices For Successful Professional Life Spirituality & Success Top 5 reasons the novel eye-drilling Nanobots could cure complex eye diseases Trending 20 32 EXPERT’S VIEWS Why technology is crucial to achieving a sustainable travel industry ? Tomas López Fernebrand | Amadeus 26
  • 7. CONTENTS 18 Bringing Breakthrough Cell Therapy Treatments to Frail Patients by Replacing Toxic Chemotherapy with a Better Alternative AVM Biotechnology: 24 30 36 Producing High-Quality Biopharmaceutical Solutions with Superior Research and Methods Driving Sustainable Growth in the Global Generics Market Proven Leaders in Stem Cell-based Regenerative Medicine BIA Separations: SANDOZ Inc: Vitro Biopharma:
  • 8.
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  • 10. Mike Suga President & CEO COVER STORY
  • 11. Performing Bioanalysis To Optimize Drug Development With Uncompromising Precision & Companies to Keep an Eye on in 2019 BEST
  • 12. In today’s healthcare industry, medicine is becoming more and more personalized with patient focused approach. To drive such a personalized medicine avenue, Biomarker is a good example and a leading contract research organizations (CRO) like CMIC, Inc. have a responsibility to provide bioanalytical data meaningful enough for advanced medicines. CMIC, Inc. is a leading CRO and a provider specialized in bioanalytical services in support of toxicokinetics (TK) as well as pharmacokinetics (PK) studies for both pre-clinical and clinical developments, along with pharmacodynamics (PD) biomarkers. Located near Chicago, CMIC provides cutting-edge capabilities and sophisticated expertise in bioanalytical method development, method validation/qualification, and study sample analysis for small and large molecules as well as oligonucleotides. As a strategic drug development partner, CMIC helps sponsors to overcome employs more than 6,000 employees worldwide with nearly $700M in sales revenue reported in 2018. Initially, CMIC grew in Asia Pacific countries and most recently, it expanded in the United States. Furthermore, CMIC Group acquired a Contract Development Manufacturing Organization (CDMO) in Cranbury, New Jersey, and JCL Bioassay, the bioanalytical test facility in Hoffman Estates, Illinois, which is currently known as CMIC, Inc. After the acquisition, CMIC, Inc.’s laboratory in Hoffman Estates completed construction of an additional 5,000 sq. ft. of dedicated laboratory space, bringing its current footprint to 27,000 sq. ft. on over 5 acres of buildable land. Currently, it houses nearly 20 LC- MS/MS instruments, bringing the CMIC global count to approximately 50 LC-MS/MS instruments. This addition provides with extensive testing capabilities and sample storage space to support increasing study demands. challenges in bioanalysis with expertise, rapid turn-around-time, and high quality services. History of Reputation and Continued Success CMIC has over 30 years of experience in bioanalytical analysis with a reputation for excellence and a strong commitment to helping improve lives of people around the world. With dedication to the drug development market and continued success, CMIC has become a leading CRO in Japan and North America. Today, CMIC continues to grow and expand its facility and capabilities to meet the needs of clients and the changing drug development environment. Growing Worldwide with its Services and Acquisitions Founded in 1992, CMIC Group became the first company to provide Contract Research Organization (CRO) services that are essential for conducting clinical trials in Japan. Today, CMIC We help clients to streamline drug development efforts to maximize success rate by reducing drug development time and costs. COVER STORY
  • 13. Managing High Volume Projects with World Class Facility Its Japan oriented-high quality, quick turn-around-time, and flexibility differentiates CMIC from its competitors. Following theses Japanese quality norms, CMIC’s GLP-compliant state-of-the-art facility has grown to accommodate quick turnaround and high volume projects from around the country. Conveniently located in Hoffman Estates only 20 minutes from Chicago O’Hare International Airport, CMIC’s location in the Midwest helps the leading CRO to conveniently serve pharmaceutical and biotechnology companies across the country. Purpose-built in 2008 to maximize efficiencies and provide scientists with a world-class quality environment, CMIC is equipped with features like on site emergency back-up power supply, Biosafety Level 2 lab, UV-free lab, controlled substance license (schedule III-V), temperature and profits sustainable for shareholders, employees, clients, and societies. Mike earned bachelor’s and master’s degrees in agricultural biosciences from University of Tokyo. Today, he is based in Chicago, where he serves as the Senior Vice President of CMIC HOLDINGS Co., Ltd., reporting directly into the CMIC Group’s Tokyo Headquarters. Highly Skilled Staff at CMIC CMIC researchers are committed to the advancement of medicine. With every project, they provide unsurpassed excellence and innovative solutions driven by CMIC’s core values of trust, teamwork, dedication, respect, and integrity. These highly educated and experienced scientists work directly with clients’ R&D scientists to ensure the best output from investments. CMIC’s project team is comprised of two technical experts for each assay performed to provide continuous verification of the assay conducted. humidity monitoring systems, video security and restricted entry, on site or off site archives, building management systems, and state-of- the-art sample monitoring system (24/7). Friendly CEO Leading CMIC towards New Opportunities “Personalized medicine is out there and it is on us by leading in bioanalytical services that clients can trust to deliver high quality data, rapid turnaround, and unparalleled customer service”, says Mike Suga, the President and CEO of CMIC, Inc., when asked about the utilization of bioanalytical services to enhance personalized medicine. Mike likes to engage with his team members by motivating them to maintain a healthy work environment. At CMIC, Mike engages with both scientific and supporting teams throughout the company’s strategy and operation as well as delivers revenues and Our mission is to contribute to high quality, efficient drug development and conduct science that contributes to the public welfare. & Companies to Keep an Eye on in 2019 BEST
  • 14. Technical expertise is shared and developed through extensive cross training between CMIC’s international laboratories. As testing methods and technology continue to improve at a rapid rate, researchers at CMIC are committed to staying at the forefront of progress with on-going education and training. Such regular external training from vendors and industry experts and regular attendance at industry conferences keeps researchers of CMIC up-to-date on the latest technology and techniques. Providing Best-In-Class Results with CMIC’s Quality Commitment The Quality Assurance Unit (QAU) at CMIC was established to provide data quality and study integrity in accordance with Good Laboratory Practice (GLP) regulations. With more than 20 years of combined experience of inspecting and auditing studies designed to comply with the US FDA and EPA as well as international regulations such as OECD and JMHW GLPs, CMIC QAU staff members are long-experienced Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP). To assure high- quality, each QAU staff member at CMIC receives on-going training and education in Quality Assurance. COVER STORY Our vision is to become the most respected and trusted bioanalytical laboratories in the world.
  • 15.
  • 16. If you wish to subscribe for Mirror Review Magazine, kindly fill out the below form and email/courier along with a cross check amounting USD $200 annual subscription including courier charges in the favor of Mirror Review Media & Technology. C-506, Wisteriaa Fortune, Opp-Silver Spoon Hotel, Laxmi Chowk Rd, Bhagwan Nagar, Wakad, Pimpri- Chinchwad, Maharashtra- 411057 +1 (850) 564-8517 info@mirrorreview.com www.mirrorreview.com Full Name: Designation: Company: Mailing Address: City: Contact Details: Mobile No.: Office No.: Email ID: Zip: State: Country: I enclosed a check/draft payable to Mirror Review Magazine: Check/Draft No.: Global Subscription Subscription Form
  • 17. Company InfoCompany Name 3Scan Todd Huffman CEO A one-stop shop for digital and computational pathology, 3Scan’s KESM produces digital 3D tissue models with micron-scale resolution at 400 times the throughput of traditional microscopes. www.3scan.com AVM Biotechnology Theresa A. Deisher CEO Founded in 2008, AVM Biotechnology is developing AVM0703—a non-toxic replacement for chemotherapy preconditioning for CAR-T/NK/TCR/TAC and other cell-based immunotherapies. www.avmbiotech.com BIA Separations Aleš Štrancar CEO BIA Separations is the leading developer of monolith technology and the exclusive producer of CIM® (convective interaction media) chromatographic columns for the production, purification, and analysis of large biomolecules. www.biaseparations.com Endo Pharmaceuticals Paul V. Campanelli President & CEO Endo Pharmaceuticals Inc. engages in the research and development, production, sale, and marketing of branded and generic pharmaceutical products primarily in the United States. www.endo.com Ipsen is a global specialty-driven biopharmaceutical group committed to discovering new solutions for targeted debilitating diseases and improving quality of life for patients. www.ipsen.com Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. www.novonordisk.com Sandoz is a global leader in generic pharmaceuticals and biosimilars. www.us.sandoz.com Established in 1986, Vitro Biopharma provides a unique mix of research and clinical products used by leading universities and institutions worldwide. www.vitrobiopharma.com CMIC Mike Suga President & CEO CMIC, Inc. is a leading CRO and a provider specialized in bioanalytical services in support of toxicokinetics (TK) as well as pharmacokinetics (PK) studies for both pre-clinical and clinical developments, along with pharmacodynamics (PD) biomarkers. www.cmic-inc.com Ipsen David Meek CEO Novo Nordisk Lars Fruergaard Jørgensen CEO SANDOZ Canada Inc. Carol Lynch President, Sandoz US, & Head of North America Vitro Biopharma Dr. Jim Musick President & CEO & Companies to Keep an Eye On in 2019 BEST Crescent Pharma Limited is committed to ensuring the manufacture of medicinal products to the highest quality, safety and efficacy by adhering to, and implementing quality systems in compliance with GMP and GDP. www.crescentpharma.com Crescent Pharmaceuticals Ajeet Nigam CEO
  • 18. Bringing Breakthrough Cell Therapy Treatments To Frail Patients By Replacing Toxic Chemotherapy With A Better Alternative According to the American Cancer Society, children treated with chemotherapy have a 3 to 13 times increased risk of getting another cancer within a span of 20 to 30 years of treatment. Despite this, chemotherapy remains the widely accepted and standard regimen for children with cancer. Developed as alternatives to chemotherapy over the past decade, treatments like Protein Kinase Inhibitors, Proteasome Inhibitors, and new Biologic Antibodies have unfortunately been a disappointment in the community setting and 41% of blood cancer patients choose to stop taking these treatments due to the physical and financial toxicities. In most cases, blood cancer patients relapse and expire rapidly after stopping treatment. Unfortunately, chemotherapy remains an integral aspect of cancer treatment, and is a required pre- conditioning before transplant or the newly approved CarT therapies. Chemotherapy comes at a price of toxic, sometimes life-threatening, side effects such as: Nausea and Vomiting, Mucositis, Leukopenia, Thrombocytopenia, Granulocytopenia, Neutropenia, Cardiotoxicity, Infections, Pneumonia, Anemia, and Hair Loss. Therefore, in the Hematology as well as Oncology field, new non- toxic solutions are needed to reduce the physical and financial toxicities of conventional treatments. Founded in 2008, AVM Biotechnology is developing AVM0703—a non-toxic replacement for chemotherapy preconditioning for CAR- T/NK/TCR/TAC and other cell- based immunotherapies. Specifically, AVM’s R&D is dedicated to the discovery, development, and commercialization of stem cell- enabling technologies for regenerative medicine, immuno- oncology, and fully human biologics applications. AVM’s Fight against Human Exploitation Based in Seattle, Washington—AVM Biotechnology is on the mission to end human exploitation whether it is physical or financial. Physical exploitation includes selling of organs in the black market and financial exploitation would include the non- reimbursement of fees in the newer cancer and autoimmunity treatments. Exploitation also includes the absence of non- injurious treatments for particular Theresa A. Deisher 18 CEO
  • 19. 19 contain potentially toxic excipients, AVM0703 is a new formulation of an existing API with a composition of matter patent filed and it is ready for Phase 2 clinical trials. In addition to its general anti-inflammatory and lympho depleting properties, AVM0703 is dosed to transiently reduce the size and number of stem cell binding niches in the secondary lymphatic system. CEO’s Multifaceted Work towards the Mission of AVM Biotechnology Theresa A. Deisher, the CEO of AVM Biotechnology is leading the company on its mission to reduce physical and financial toxicities of cancer and autoimmune treatments, which will ultimately improve patients’ quality of life. At AVM Biotechnology, Theresa oversees all the Research and Development as well as clinical development. She also handles patent strategy and patent writing. Moreover, the multi- talented CEO looks at recruitments of key personnel to further expand the corporate capabilities of AVM Biotechnology. Along with these key patients like the elderly, children, the poor or disabled. AVM has set its goal to fight against such exploitation and work towards improving patients’ quality of life, reducing physical and financial toxicities of cancer and autoimmune treatments, and the elimination of the dread a cancer or autoimmunity diagnosis brings to patients and their loved ones. AVM0703 acute actions are relatively selective for lymphocytes, reducing the risks of infection, the need for hospitalization, transfusion requirements and patient toxicities. After a single acute IV dose, it delivers rapid clinical responses within 24 hours. Importantly, AVM0703 treatment can be safely repeated upon relapse allowing cancer or autoimmunity to be either cured or made chronic with good quality of life. How AVM0703 Reduces Toxicity? AVM0703 is used alone, or in combination with stem cell-based therapies, to significantly enhance stem cell tumor targeting and engraftment. AVM0703 lymphoablates all compartments and has the ability to replace chemotherapy preconditioning before transplant or adoptive cell therapy. It can be used as a stand-alone treatment which is projected to induce remission in relapsed/refractory lymphocytic blood cancers and patients with autoimmune disease who have not responded to DMAIDs (Disease- modifying anti-inflammatory drugs). As compared to commercially available versions of the API, which We strive to develop products like AVM0703 that will end human exploitation in biomedical research and medical treatments. & Companies to Keep an Eye On in 2019 BEST aspects, Theresa takes care of fund raising for new developments and improvements in the existing programs at AVM Biotechnology. Strategies to Reach Under- Developed Nations with New Partnerships When asked about her long term plans for AVM Biotechnology, Theresa said that they have plans to partner with a global pharmaceutical company for worldwide clinical development and commercialization of AVM0703 and their second generation candidate. An important part of their long-term mission is to provide AVM therapies to under- developed regions of the world. Additionally, Theresa and her team are working on accelerating clinical trials in autoimmunity and use of AVM0703 as a non-toxic preconditioning agent to optimize stem cell regenerative effects. For this, they are leveraging clinical dosing and safety data from relapsed/refractory lymphocytic blood cancer patients, where FDA commercial approval is rapid. The revenue generated from AVM0703 will be used to drive another development program leveraging induced pluripotent stem cells (iPS). This program will be useful for general and patient-specific biologic manufacturing. Likewise, AVM Biotechnology will partner and collaborate with companies who are developing novel bioreactors and NGOs to solve supply chain limitations of vaccine provision in under-developed countries.
  • 21. S pirituality in the business is a movement that began in the early 1920’s and has emerged as a grassroot movement with individuals practicing spirituality in the workplace. Most recently, employees have started looking beyond the jaw-dropping salary packages, and for them money is not the only prominent motivator of good job performance, because they want mental satisfaction from their work as well. The feeling of fulfillment, in other words, is called as spiritual fulfillment, which is a major motivator for delivering a better job performance. Spirituality involves the attempt to seek one’s ultimate purpose in life, and spirituality in business involves developing a strong connection with oneself and one’s co- workers, having ideal beliefs and spiritual values. The spiritual values include values of work ethics, a good cause to work for the company, empowerment, and expression of emotion, which plays an important role in the employee’s life. Sometimes, spirituality is confused with religious tradition, but it does not involve a connection to any specific religion, rather it is based on the individual’s own personal values and philosophy. The present article elaborates how the business and spirituality work together for a successful professional and personal life. Ø Daily morning spiritual practices: The spiritual practices balance the life. The practices such as meditation, yoga, and breathing exercises help people to connect with themselves. According to a book on spirituality written by Florence Scovel Shinn, the subconscious mind needs programming, and if it’s not done then someone else will program it. Nowadays, without spiritual practices, people let others do the programming through the social media, news, and other informative mediums filled with a mixed type of expressions, which disturbs the focused thought process of an individual. The morning practices make the mind more focused and program it in such a way that the employee can sustain the new work challenges and unexpected events throughout the day. The start of the day with these spiritual practices awakens the individual and makes him realize the happiness and peace within by detaching him from the deep dreams of other attractions. To make the mind feel great and alert throughout the day, starting the spiritual practices early in the morning after a complete 8 hours of sleep is beneficial as it is very peaceful and quiet in the morning. After starting to wake up early in the morning, it becomes a supplement for the healthy expansion of the entire life. Committing few spiritual rituals every day can absolutely change the life in a positive way. Sometimes, it’s difficult to meditate just after waking up, because many people go back to sleep while meditating. Taking a simple tea can change the entire ritual, because the caffeine in the tea is a perfect wakeup call so that one can work without dozing off. Those who don’t like tea can sit and write something to regenerate the energy. Writing opens the thoughts and ideas in the mind. If an employee is going through a tough time, writing is the best solution to find out the best solutions. & Companies to Keep an Eye On in 2019 BEST 21
  • 22. Ø Time to connect spiritual source during work: Most of the successful professional individuals schedule a break during the day to do walking, meditation and jog while concentrating on breathing, or they sit quietly away from everyone and everything to meditate. Sitting quietly with eyes closed, along with the focus on breathing will help to clean the mind which is continuously thinking and analysing about something or the other. Even if these thoughts come and go, and one must not be taunted by them. With consistent practice, they will vanish keeping the mind a quiet place. These procedures generate the conscious power within and bring the inner bliss to come out and cherish. An alarm and a timer will be beneficial for doing such practices. This small time taken for connecting with oneself simplifies and makes the workday more successful. Organizations should promote these practices and create a calm and healthy atmosphere for them because employees desire to work in an organization that seeks to have a high sense of ethics or integrity and makes a good contribution to the welfare of employees, customers, and society than the typical company. Ø Trashing out the negative thoughts: If the employee is filled up with negative thoughts and emotions, which are not serving him, then there won’t be enough space available for receiving the desired outcomes. Imagine a glass of dirty water filled to the brim. If one needs to add pure water in it, then it’s not possible to add pure water in an already full glass. The same is true for the mind. When the mind of an employee is full of worries, anger, grudges, judgments towards co-workers or himself, he won’t be able to utilize and think about pure thoughts of contentment, because the mind is already engaged in thoughts related to other negative feelings. It is essential to trash out such negative feelings to welcome positive things to happen. Finding a practice which releases negative emotions is the best way to deal with the negative thoughts because only a calm and happy mind can understand the inner intuition or the gut. A clear and happy mind helps employees understand how they feel about new tasks, projects, and organizational activities. There is a close relation between good thoughts and job satisfaction, because, in work, the positive organizational purpose is significantly associated with job satisfaction. With an increase in workplace spirituality, employees’ commitment increases towards the organization. Ø Spirituality for leadership: For many years, spirituality and leadership were worlds apart. While spirituality concerns with intangible ideas and emotions, leadership is a practical area of scientific inquiry. However, a large number of evidences from studies show that these fields are much closer, and there is a transition between the two figures. A good leader needs to evaluate the situation and act accordingly. The key elements of modern leadership involve co- operation, consideration, agreement, and social quality. The new adaptability culture requires a leader to be autonomous, take initiatives for improvements and emerge with new objectives and strategies. There is growing interest in the issues related to the spirituality in the workplace. The spiritual values such as integrity, honesty, and humility have a great effect on leadership success. The practices which have been emphasized in many spiritual teachings, and found crucial for leadership development are: showing respect for others, demonstrating good treatment, expressing caring and concern, actively listening, recognizing and appreciating the contributions of others, and engaging in reflective practice. Leadership and spirituality play an essential role together in terms of ethics and values. Value-based leaders have the ability to utilize employee efforts and organizational goals more effectively by connecting them to the deeper values inside them. They motivate employees and improve their performance and commitment towards the organization by making them imagine a better tomorrow. The spiritual rituals have an uncanny ability to set the human mind for the rest of the life. These spiritual practices also give a loud and clear message that the professionals in organizations should be versed with their core values through a positive vision and personal actions. People commonly believe that there is a conflict between the values and practices included in spirituality and those required for successful business, but the above article explains the huge similarity between elements of success in both fields. Therefore, by incorporating these spiritual practices in professional life, employees can align good values with the strategy and roadmap to achieve massive success in the business. Spirituality & Success 22
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  • 24. Producing High-quality Biopharmaceutical Solutions With Superior Research And Methods manufacturing and sales of monolithic chromatography columns. Its columns comprise a range of large molecule isolation and purification products used in the development and production of gene therapy including Cas/Crispr, CAR-T, on colytic/viral vaccine, phage, exosome, and plasma products. The leading Slovenia-based company provides customers with significant yield, purity, cost, and process speed advantages over competing technological solutions as well as usage flexibility in downstream processing of pDNA, viruses, VLP, phages, exosomes, and large proteins. BIA Separations’ unique polymer composition, precise flow- through channels, and high surface accessibility of binding sites result in elevated binding capacities, exceeding those of resin-based columns and allowing rapid mass transfer with very low shear force effects and product degradation. BIA Separations’ columns are differentiated by their flow independent performance, resulting in fast separation, concentration, purification, removal, and analytics of biopharmaceuticals. Additionally, they are available in different designs and capacities to meet the specific needs of its client base, which ranges from small-scale laboratories to full- scale manufacturing facilities. Best Selling Services of BIA Separations Having 20 years of experience with over 500 running projects, BIA Separations helps clients with products like unique monolithic columns and Purification Process Development for clinical phase serotypes trials and market supply of AAV, Flu virus, Adeno, Vaccinia/MVA, exosome, pDNA, mRNA, IgMs, PEG-proteins, liposome, ribosomes, bacteriophages, vaccines, and other complex biomolecule based biopharmaceuticals. Ÿ Monolithic Columns: With well- defined channel size distribution, ® CIM monoliths contain highly cross-linked, porous poly- methacrylate material. Moreover, the high surface accessibility of binding sites allows rapid mass transfer based on convection. BIA Separations’ chromatography products are distinguished for their flow-independent performance, low back pressure, and versatility, resulting in faster separation, concentration, purification, removal, and analysis of biologic materials. Using unique monolithic columns and Purification Process Development, the resulted process allows for higher yield and purity of client’s target product. This is possible due to BIA Separations’ capability to manage the interface between upstream and Ales Strancar CEO 24 Traditional Pharma techniques have struggled for decades to make inroads into diseases whose roots lie deep in molecular biology. Today’s modern Biopharma has extended that reach into the foundations of cancer, heart disease, genetic disease, and a host of other afflictions. In the coming years, the therapies and cures offered by this extended reach will increasingly enable patients to live longer with productive and more fulfilling lives. Beyond that, these modern therapies will also enable the prevention of numerous diseases and conditions that have plagued humanity for centuries. Established in 1998, isBIA Separations the leading developer of monolith technology and the exclusive producer of CIM®, Convective Interaction Media chromatographic columns for the production, purification, and analysis of large biomolecules. Core Focus Areas of BIA Separations BIA Separations specializes in the
  • 25. organization, supporting and motivating employees, formulating policies, overseeing organizational operations, looking for future opportunities, implementation of plans, and much more. In addition to these roles and responsibilities, the energetic CEO of BIA Separations also likes to be a part of the new product and process development. Standing Apart from Competitors with High-Performance Products BIA Separations is always one step ahead of its competitors with its genuinely unique and extraordinary fractionation performance. No other chromatography media format can match monoliths for capacity, speed, resolution, recovery, and convenience, especially with very large products like DNA plasmids, RNA, virus particles for vaccines and viral vectors, and extracellular vesicles. In addition, Slovenia-based company’s deep hands- on experience with method development for these same products puts its customers years ahead with process development, clinical evaluation, and manufacturing. Other than its products, BIA Separations is known for its following best-in- classfacilities comprising: 1. Process Development: As a contract research organization, downstream processes, which is the key for complex biologics production, and use of monolithic chromatographic resins, which provide the best performance for complex biomolecule purification. Ÿ Products for Analytical Applications: CIMac™ Analytical Columns combine all elaborate ® characteristics of CIM monoliths at analytical scale and are perfect tools for analysis and control of manufacturing processes as well as they are ideal for process analytical technology (PAT). Ÿ Products for Preparative Applications: CIMmultus™ is the new and improved line of pre- packed chromatographic monolithic columns distinguished by large flow-through channels, designed for working with large proteins like IgG, IgM, PEGylated, and VLPs along with viruses like AAV, adenovirus, lentivirus, influenza, bacteriophages, and pDNA. TM Ÿ PATfix : Using CIMac™ TM analytical columns, the PATfix HPLC system gives “at-line” analysis for the control of impurities and critical quality components using HPLC fingerprinting. CEO’s Contribution to BIA’s Success Since taking over the responsibility as the CEO of BIA Separations, Ales Strancar has been enhancing the capabilities of the leading biopharmaceutical solutions provider company. With a goal to make BIA Separations as the number one supplier of purification products and supporting services in the field of Gene Therapy, Ales handles numerous roles and responsibilities, which consists of managing the company, making everyday business decisions, advising the Managing Board, promoting We offer a whole toolset for chromatographic analyses of molecules in up and downstream processes in minutes. BIA Separations’ facilities are fully equipped to handle process and analytical method development for particles up to biosafety level 2. Considering clients’ demands in mind, its sales and technical support team prepares a work plan as per their requirements. Moreover, clients’ may choose to be involved throughout the development via regular contact with the project manager. 2. Downstream Process Development: Ÿ Processes suited to different clinical phases up to market supply are developed exclusively on monolithic columns starting from lysis or capture to final polishing and formulation of biomolecule like viruses, pDNA, bacteriophages, extracellular vesicles, proteins, PEGylated proteins, etc. Ÿ Depending on clients’ products and requirements, the multistep process includes development of lysis method, chromatographic media selection and optimization, virus inactivation, filtration, and tangential flow filtration. Ÿ Recommendation of suitable analytical methods. Ÿ Tech transfer of standard operating procedures (SOP) to client’s facility or CMO. 3. HPLC Analytical Methods: Ÿ Methods for in-process control (PAT), which are developed to increase control, improve efficiency, and prevent rejection of batches of upstream and downstream. Ÿ Methods for final control that enable real-time release of products. Ÿ BIA’s HPLC methods use CIMac™ Analytical Monoliths and are developed on PATfix™ along with reference methods for characterization. All these methods can be validated. 25 & Companies to Keep an Eye On in 2019 BEST
  • 26. Do you believe in the importance of a sustainable travel industry? The travel and tourism sector is expected to grow at an annual rate of 3.9% over the next decade. That is positive, but it also reminds us that we need to put in place measures to guarantee the sustainability of the sector in the long term. Amadeus takes this very seriously. Let me tell you why. We consider that a company’s responsibility goes beyond securing the growth of its results. At Amadeus we have a record for many years of limiting the environmental impact and optimizing the social reach of our commercial operations. We believe that environmental efficiency has to start with our internal operations. That is why we measure our environmental impact in order to identify improvements and implement solutions. Since 2009, we have been using the Amadeus Environmental Management System (EMS) as a solid methodology to analyze all our environmental data and help us identify and take measures to improve environmental performance. As a technology provider for the travel and tourism sector, Amadeus develops technology solutions that help our customers improve their environmental and economic efficiency. One of our technology solutions, Amadeus Altéa Departure Control-Flight Management, allows airlines to accurately calculate the fuel they need for a given flight, allowing them significant savings in CO2 emissions, fuel and economic costs. To achieve greater long-term results, we collaborate with other interest groups in the travel industry and participate in projects to improve environmental sustainability. For example, in order to help achieve the 2-degree objective set by the Paris Agreement and reach the carbon neutral level, Amadeus joined the United Nations’ Climate Neutral Now commitment. We have also established a long-term agreement with the International Civil Aviation Organization (ICAO) to contribute to a greater awareness of carbon emissions in aviation. Amadeus uses the ICAO carbon emissions calculator on its distribution platforms to provide travelers with information on the greenhouse gas emissions produced during their trips. Why TECHNOLOGYis Crucial to Achieving a Sustainable TRAVEL INDUSTRY? Expert’s Views 26
  • 27. Amadeus’ environmental commitment is reflected in our inclusion in several global sustainability indices. Among others, Amadeus has been chosen as one of the most sustainable companies in the world, ranking 16 in the 100 global companies chosen by Corporate Knights in 2018. In addition, our efforts in this regard have been recognized by the Dow Jones Sustainability Index for seven consecutive years. Looking at the social level, we believe that travel can play a key role in global economic development and can be a determining force for positive change. We seek to actively contribute to the communities in which we work, through investment, participation in local projects and partnerships with non-profit organizations around the world. To do so, during 2017 we developed 138 community support and social assistance projects and 69 training projects, providing young people with the qualifications required by the digitized sector of travel and tourism. In 2013, Amadeus launched Click for Change, a program that, thanks to the donation engine developed by Amadeus, allows donations from people who buy their trips online. So far, travelers have donated almost 3 million dollars on the websites of Iberia, Finnair, Norwegian, Almundo and Avianca for programs to educate and vaccinate of children, and other development projects run by the United Nations Fund for Children (UNICEF). We also contribute our knowledge in travel intelligence for initiatives that benefit society. In this sense, Amadeus is part of a UNICEF global innovation program that collects and analyzes complex data sources from different sectors. In part, thanks to the data provided by Amadeus, they can better understand the patterns of the spread of epidemics, which helps them to control possible outbreaks in other areas. Our purpose to shape the future of travel and tourism is based on internal, external and collaborative actions with other entities in the sector. We are committed and proud to be able to use Amadeus’ technology, experience and global network to ensure the sustainability of the travel industry in the long-term and build a better future for all. Senior Vice President, General Counsel & Corporate Secretary, Amadeus Tomas López Fernebrand 27 & Companies to Keep an Eye On in 2019 BEST
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  • 30. Driving Sustainable Growth In The Global Generics Market Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of Novartis, its purpose is to discover new ways to improve and extend people’s lives by pioneering novel approaches to provide access to high-quality medicines. Global headquarters are in Holzkirchen, Germany and US headquarters in Princeton, New Jersey. With its experience and capabilities in the development, manufacturing and commercialization of medicines, Sandoz is committed to increasing patient access to high- quality, life-enhancing biosimilars and Value-Added Medicines (VAMs). According to estimates, 1.2 million US patients could gain access to biologics alone by 2025, which is beneficial to all, particularly the elderly, women and those with low or fixed incomes. Sandoz is boldly trailblazing novel approaches to supporting the growing healthcare needs across the world. Reducing the Rising Treatment Cost with Biosimilars and Generic Medicines As it continues to reimagine medicine, Sandoz has focused its strategy on specialization in biosimilars, VAMs, complex generics and prescription digital therapeutics, in order to contribute to helping patients gain access to cost-effective and advanced health treatments. Of note are three medicines that held top market share positions in ® 2018. Zarxio (filgrastim-sndz), which stimulates growth of certain white blood cells important to fighting infection, ® Omnitrope (somatropin injection), a human growth ® hormone, and Glatopa (glatiramer acetate injection) for relapsing forms of multiple sclerosis. As of October 2018, ® Zarxio led with over 45% share; ® Omnitrope reached its highest total prescriptions (TRx) share with over 24% in a seven-player market and growth of more than ® 20% and Glatopa 20 mg/mL continued as the market leader with 38% TRx share. The successful adoption of ® Zarxio into clinical practice saved the US healthcare system about $500 million in less than two years. Backing the Prescription Digital Therapeutic (PDT) Arena Another exciting milestone on its Carol Lynch President, Sandoz US & Head of North America, Sandoz Inc. 30
  • 31. 31 of an originator reference product in the US and remains in the top spot in volume share. Carol Lynch, Leading the US Transformation of Sandoz Carol Lynch has worked with Sandoz and Novartis for more than 20 years in various roles across several continents. Due to her dedication and extensive experience with Sandoz and Novartis, Carol became President, Sandoz US, Head of North America, Sandoz Inc. in March 2018 and is a member of the global Sandoz Executive Committee. Carol oversees commercial operations in the US (the largest commercial and country organization) and Canada and looks after 35% of Sandoz’s global revenue. journey to reimagine Sandoz was expanding its presence in the digital world. It has collaborated with Pear Therapeutics, enabling it to leverage new technologies and be at the forefront in the digital revolution. In December 2018, ® Sandoz launched reSET , the first and only FDA-authorized Prescription Digital Therapeutic (PDT) that leverages technology to strengthen Substance Use Disorder (SUD) therapy. Further, in January ™ 2019, it launched reSET-O , the first FDA-cleared PDT for patients with Opioid Use Disorder (OUD). These flagship launches are proof of Sandoz’s dedicated efforts in identifying innovative solutions to major healthcare issues like the opioid abuse crisis in the US. Biosimilars as the Solution for Expensive Health Treatments As stated by the Association for Accessible Medicines (AAM), biosimilars have the potential to improve the quality of life for American patients and save billions of dollars each year. It is estimated that biosimilars could save the US healthcare system more than $54 billion over 10 years. Sandoz was the first company to bring biosimilars to US patients. It is also further backing the movement for cost-effective medicines with eight biosimilar medicines approved worldwide. ® Sandoz’s Zarxio is the first biosimilar to overtake market share We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high- quality medicine. & Companies to Keep an Eye On in 2019 BEST Carol appreciates working with smart, strategic people because it helps to promote creativity that will fuel the reimagining of the US business. She believes that one must find purpose in their work and be empowered to improve ways of working to more positively impact patient’s lives. Currently, Carol and her team are taking bold actions to transform the US business for sustainable long- term growth. To create higher future value, Sandoz is reshaping its portfolio to complement complex generics and biosimilars with VAMs and prescription digital therapeutics. According to Carol, the company will continue to explore and implement cost-effective biosimilars, complex generics, and PDTs to innovate more accessible solutions that will enrich people’s lives. When asked about her upcoming strategies for Sandoz, Carol asserts, “Our work is not close to being finished. We have several exciting new product launches planned for early 2019, with more to come throughout the year. We are working hard to bring our own portfolio to the market, but more importantly, we are seeking innovative partners who need a strong commercialization collaborator to bring their products to market, too.”
  • 32. Ateam of scientists created specially coated nanometer-sized vehicles that can be used to move through dense tissue of the eye. Until now, scientists have successfully transported nanobots or nano- vehicles in model systems or through biological fluids. This is the first time nanobots could drill into a real tissue of eyeball. These nanobots are just 500 nm wide and they can easily roam through the tight molecular matrix of an eye. To go further, a clear idea about nanobots is essential. What are nanobots or nanorobots or nano-vehicles? Nanobots are the robots of size close to the microscopic −9 scale of a nanometer (10 meters). So far, nanorobotics considered as hypothetical nanotechnology engineering discipline of designing and building nanorobots. When nanobots in medicine are considered, the most popular idea is self-propelled nanomotors and other biodegradable nanodevices made of bio-nano components. They are used to carry cargo to the target sites. It means they deliver drugs to diseased cells. Such drug delivery approach promises an effective and improved transport of drugs compared to conventional methods. For instance, scientists can program nanorobots to transport essential drugs to remove blood blockages, which can cure the tumors. A team of international scientists of the Micro, Nano and Molecular Systems Lab at the Max Planck Institute for Intelligent Systems in Stuttgart performed comprehensive research on these eyeball-drilling nanobots. The research is named as “A swarm of slippery micro- propellers penetrates the vitreous body of the eye”, by Zhiguang Wu, Jonas Troll, Hyeon-Ho Jeong, Qiang Wei, Marius Stang, Focke Ziemssen, Zegao Wang, Mingdong Dong, Sven Schnichels, Tian Qiu, Peer Fischer, published in Science Advances (2018). Based on the above research, this article covers some aspects of these novel nanobots and their role in curing eye diseases. Here are some of their key features: 32 Trending
  • 33. Top5the novel eye-drilling Nanobots could cure complex eye diseases reasons Ÿ A size which can easily roam inside an eye Covered in a non-stick coating, these nano-drills are 500nm wide size approximately matches the mesh size of the network in the vitreous. They are helical in shape and 200 times smaller than the diameter of a human hair. This size is even smaller than a bacterium's width. Researchers call it slippery micro-propellers. Ÿ Slippery surface coating inspired by nature Most tissues including the vitreous have a tight macromolecular matrix that acts as a barrier and prevents its penetration. Surprisingly, the slippery coating on these nanobots removed this barrier of penetrations. This enables the nanobots to move in the vitreous seamlessly. The slippery exterior allows them to be actively propelled through the vitreous humor to reach the retina. Primarily, all this happens without damaging the sensitive biological tissues around them. One of the authors of the study, Zhiguang Wu explains, “For the coating, we look to nature for inspiration”. Further, he added, “In the second step, we applied a liquid layer found on the carnivorous pitcher plant, which has a slippery surface on the peristome to catch insects. It is like the Teflon coating of a frying pan.” The first film of slippery coating on these nanorobots consists of molecules bound to the surface, while the second is a coating with liquid fluorocarbon. This clever combination enables the nanorobots to go through the tight mesh of the eyeballs dense tissue. This slippery coating is crucial for the efficient propulsion of robots inside the eye, as it minimizes the adhesion between the biological protein network in the vitreous and the surface of nanorobots. Ÿ Targeted delivery Traditional delivery methods rely on the random, passive diffusion of molecules. These methods do not allow for the rapid delivery of a concentrated cargo to a defined region of the eye. The use of particles promises targeted delivery but faces the challenge of macromolecular resistance. 33 & Companies to Keep an Eye On in 2019 BEST
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  • 36. Proven Leaders In Stem Cell-based Regenerative Medicine The Need for Regenerative Therapies It is clear that the current healthcare sector needs a shift towards regenerative therapies to help the correction of underlying diseases by utilizing innate healing systems as opposed to therapies based on symptomatic interventions with attendant side effects, comorbidities and excessive costs. By “Harnessing the Power TM of Cells , the US-based Vitro Biopharma is focused on achieving the full potential of regenerative medicine. Established in 1986, Vitro Biopharma provides a unique mix of research and clinical products used by leading universities and institutions worldwide. Over the last 25 years, it has been providing human stem cell lines and related primary cells for use in research, drug discovery/development, and pre- clinical studies. Vitro provides a unique competitive advantage through the supply of the highest quality stem cells coupled with stem cell activation therapy and molecular diagnostics to track relevant biomarker profiles, allowing the assessment of stem cell regeneration. Along with this extensive experience, Vitro possesses expertise in highly- regulated, commercial biologics manufacturing. The Company is ISO 9001:2015 certified, cGMP compliant, FDA and CLIA registered as well as ISO 13485:2016 compliant. International Stem Cell Trials utilizing advanced medical diagnostics and therapies With its vast history of working in the healthcare sector, Vitro has developed innovative products in medical diagnostics, cancer research, cell line regeneration, and stem cells. Essentially, its cell lines include primary and cancer- associated fibroblasts and animal & human mesenchymal stem cells (MSCs) derived from various tissues together with MSC- derived progenitor & terminally differentiated cells like dopaminergic neurons, cardiomyocytes, etc. Similarly, it carefully tests cell lines for purity, integrity, and contaminates. This leading biopharma company is Dr. Jim Musick 36 President & CEO
  • 37. 37 outcomes are the results of the dedicated efforts made by Vitro’s talented CEO and his skilled team. Through its outstanding portfolio of products and services and exemplary contributions to the healthcare industry, Vitro Biopharma has received several elite recognitions. In 2014, it was recognized by Frost and Sullivan as a “Thought Leader in Stem Cell Tools & Technology” in North America through the Receipt of a Technology Innovation Leadership Award. Similarly, the company was also recognized for its accomplishments in stem cell lines and media for supporting global stem cell research and its innovative stem cell activation technology. The company has numerous national and international patents and patents pending on its intellectual property. also currently focused on stem cell therapies for a variety of conditions including neurodegenerative diseases, musculoskeletal conditions like osteoarthritis, and conditions characterized by inflammation. The company’s breadth of services and products is unique in the industry. Vitro’s strength in research provides a platform for extension to clinical studies, through the supply and knowledge of all essential components of modern stem cell therapeutics under appropriate oversight by regulatory agencies. The company has ongoing clinical trials in the Cayman Islands, New Zealand, the Czech Republic and has recently received approval for a new stem cell therapy trial for musculoskeletal conditions from the Ministry of Health in the Bahamas. Improved Results with Vitro Biopharma’s Stem Cell Activation Product At present, Vitro Biopharma offers a nutraceutical product, NutraVivo™/Brain Grow Technologies™ for health benefits of stem cell activation. With the use of NutraVivo™, the company has tested successful activation of human neural & mesenchymal stem cells by enhanced migration & proliferation as well as enhanced gene expression. These superior Vitro Biopharma provides and continually improves the highest quality stem cells and related products and services in accordance to government regulations. & Companies to Keep an Eye On in 2019 BEST CEO, Accelerating Vitro with Advanced Regenerative Medicine Applications Dr. Jim Musick, the President and CEO of Vitro Biopharma, is currently handling the operations of this rapidly growing stem cell firm. Along with his committed team, Jim is involved in research & development and oversees the essential processes including intellectual property development, marketing, sales, business development and new product releases. With his mission to ease patient care, Jim proudly asserts, “My greatest pleasure comes from seeing a patient’s favorable response to our stem cell therapy. We are beginning to see advances in diseases with limited or not treatment options other than stem cell therapy” Additionally, with these continual positive outcomes and deep insights, Jim is currently working towards expanding Vitro’s presence in international medical tourism while simultaneously pursuing opportunities in the US markets such as a new cosmetic stem cell serum product.